Stanislaw Burzynski and the cynical use of cancer patients as shields and weapons against the FDA

I realize that I just wrote about infamous cancer doctor Stanislaw Burzynski yesterday. (Note how I refuse to call him an “oncologist,” mainly because he isn’t one, having never completed an oncology fellowship—or even an internal medicine residency, the usual prerequisite to do an oncology fellowship.) However, there’s a bit more that I wanted to touch on before moving on to other topics. What brought this on was a Google Alert that appeared in my in box yesterday relevant to yesterday’s post. You might recall that yesterday I mentioned a campaign by the Alliance for Natural Health USA (ANH-USA) to encourage people to write to their legislators to put pressure on the FDA to allow Stanislaw Burzynski to treat patients with inoperable brain cancers on compassionate use protocols and, of course, to attack Burzynski’s critics, in particular Liz Szabo and the newspaper that published her expose of Burzynski, USA TODAY. A key aspect of this campaign by the ANH-USA was a claim that somehow the FDA had violated the privacy of one of Burzynski’s patients by providing to Szabo some of his medical records included in records of its investigation. This led ANH-USA to proclaim:

The FDA violated Burzynski patients’ privacy. “A lot of our patients were obviously very irked about the article, and called the USA Today team,” a Burzynski staff member told us. “The parents of one young patient called a USA Today reporter, who then sent the parents their own child’s confidential medical records—which the reporter had received from the FDA. The family frantically called us [the clinic], ‘I just got an email from USA Today, they sent me our son’s full medical records!’” The reporter had sent not only the son’s medical records, but those of other patients as well.

Don’t bother clicking on the link. As I mentioned in yesterday’s post, it’s dead. At the time, I wondered why. Now, thanks to my Google Alert, I know. The ANH-USA actually admitted screwing up:

In our recent article “Dying Patients Denied Access to Dr. Burzynski’s Potentially Lifesaving Treatment,” we quoted a Burzynski clinic employee who stated that the FDA shared private medical records with a USA Today reporter. We have since learned that this was not accurate.

USA Today’s reporter had previously stated, “I read about N’s case in a document that Dr. Burzynski sent to the FDA, in response to its ongoing investigation.” This seemed to confirm the allegation that the FDA had given the reporter confidential patient information. However, in response to our article, the reporter now says, “Those patient records did not come from the FDA, so there was no privacy violation on their part.” The first statement appears to have been an attempt to protect the identity of the person who did provide the confidential patient information.

My guess is that, given its previous history, the ANH-USA must have found out a doozy of a—shall we say?—inconvenient fact to have not only removed its original attack on Liz Szabo and USA TODAY but also to have admitted that it had screwed up. Anyone want to bet that it was the Burzynski Clinic that sent those records in error? It wouldn’t surprise me. Whatever the case, however those records got out of the Burzynski Clinic, this explains why the ANH-USA article is gone from its website. That might do it. Other ideas might come to your mind to explain this rather startling development.

Attacks from the ANH-USA on Szabo and Burzynski critics are understandable. That’s it’s MO, its raison d’être, if you will. It exists to promote “natural health” (whatever that means), and for whatever reason that toxic mass of chemically synthesized peptides known as antineoplastons, manufactured by brave maverick doctor Stanislaw Burzynski, has somehow become considered to be “natural healing,” rather than what it really is, chemotherapy. Again, although it’s puzzling that the ANH-USA would view chemotherapy like Burzynski’s ANPs as “natural,” it’s not at all surprising that, once having made that determination, it would attack Burzynski critics or anyone exposing the truth about what Burzynski does. Again, the ANH-USA is ideologically committed to treatments like Burzynski’s.

I can also understand why cancer patients and their families would rally around Burzynski, at least the ones who have come to believe in him. That’s even easier to understand than why the ANH-USA would rally around him. These patients and families really and truly believe that Burzynski is the only one who can save them or their loved ones. Faced with the prospect of impending death, no price is too much to pay, and no countering information can be tolerated, because the alternative if Burzynski can’t do what he claims to be able to do is too terrible to contemplate. This is why families like those of McKenzie Lowe, Refael Elisha Meir ben Devorah Cohen, and Eliza Cozad, for example, go to such lengths to raise money. Even after Szabo’s expose, these patients’s families believed. Burzynski is expensive, but who can put a price on the lives of their loved ones, even if there are critics and doubts? Before them there were many more, as I’ve documented over the last couple of years.

The first was Burzynski himself. I first wrote about Burzynski very briefly in a cover story about a new book on alternative medicine, which was, as our lawyer described it, a “longish book review.” As part of my routine reporting, I emailed Burzynski for a response to the book, which was not flattering to him.

I expected Burzynski to ignore me or decline the interview. Instead, I got an 8-page response from his attorneys, warning us of the dangers of writing about their client. That was a first. I’ve never in my life gotten a legal warning about a story before I’ve even written a word. It was a red flag. Also, it was hard to believe that his lawyer could really whip up a letter like this in 24 hours. It seemed more likely that the lawyer had it on file and was perhaps in the habit of sending legal warnings to journalists. That bugged me. Whenever someone works that hard to keep a story from being published, it’s a pretty good sign that you need to write it.

Ironically, Stanislaw Burzynski and his lawyer Richard Jaffe might very well have brought Szabo’s investigation on themselves. If they had just ignored her or given a perfunctory or unenlightening response, her interest in the story might never have been piqued, and that devastating USA TODAY article might never have come to be. Worse, she discusses the families:

One couple wrote to say that they are still hoping to see Burzynski, and they’re actually petitioning the FDA to get his trials reopened. It was difficult to know what to say to them. They are undeterred by all the criticism.

She also notes that the people seeking out Burzynski and attacking her are, by and large, good people in bad situations. So even after the expose in USA TODAY, people still want to see Burzynski; they are still raising money; and, as I discussed yesterday, they’re even resurrecting an old strategy that Burzynski used the last time his back was really up against the wall in the mid-1990s. The fundraising campaigns and campaigns to lobby Congress suck in more than just those directly involved with the families and patients, too. They suck in local businessmen, who, for example, donate proceeds from their pizza restaurant to funds set up by the family of a Burzynski patient, reminiscent of the sorts of fundraising efforts inspired by patients like Hannah Bradley, Laura Hymas, Amelia Saunders, and many others.

I’ve always wondered what the source of the power of purveyors of dubious cancer treatments is. Patients and families are the source of their power, yes, but that doesn’t explain it all, because they are a relatively small number of people in the grand scheme of things. Their belief, however, is incredibly intense, and the intensity of their belief serves as the nidus of a community. That pizza shop owner in Nashua, NH believes he is doing great good by raising money for McKenzie Lowe’s campaign and by gathering signatures on petitions to the FDA and lawmakers to grant compassionate use exemption for ANPs for these patients. U.S. Sen. Kelly Ayotte (R-NH) believes she is doing good for one of her constituents by writing a letter to the FDA asking the FDA Commissioner not to “stand in the way when no other treatment options are available for an already terminally ill child.” The Jewish communities that have rallied around the plight of Raphael Elisha Meir ben Devorah Cohen to raise well over $100,000 and over 100,000 signatures on a We The People petition, enough signatures that the Obama administration will have to respond. The campaign has even gone international, with stories appearing in Israel and other Jewish communities around the world. Basically, what “brave maverick cancer doctors” like Burzynski do is to pervert the best instincts of humans, the desire to help a fellow human in distress and to build communities to do it. These communities spring up to help, and they end up becoming tools of the Burzynski advertising machine.

Aiding and abetting this is another good human trait, the desire to think the best of people, to respect others, to let them find their own way without interference. How this is used as a sword and shield, like the patients, against Burzynski critics is exemplified by a post by Randy Barnes, who argues that we should “respect” the parents of Elisha Cohen:

I am not a fan of the Burzynski Clinic, and I agree with many of the criticisms leveled at Stanislaw Burzynski and his treatments. But this is not about my opinion of the clinic. Raphael Elisha’s parents are the only ones with the right and responsibility to make the best decisions they can in a horrible situation that no one who has not faced the loss of a child can possibly understand. The Cohen family is fully aware of the controversy. They have read the articles on the clinic. However, they have also spoken to people who are convinced that Burzynski cured their cancer. As Raphael Elisha’s parents, they have decided to pursue this course of treatment if it is made available.

In the meantime, the family continues its frantic race against time as they search across the globe for other experimental medications that could be a fit for Raphael Elisha. And friends and supporters of the Cohens continue to pray, donate money, and sign the petition.

None of this, unfortunately, does Elisha any actual good with respect to his cancer. I realize that what I said can come across as harsh and that some families are likely to react very negatively to it, but it’s true. The community that has sprung up around Elisha Cohen might provide emotional support and make the family feel good, but ANPs will not help Elisha. These petitions will not help Elisha survive his cancer. The same is true of all the other cancer patients whose families are petitioning the White House, their legislators, and the FDA in Stanislaw Burzynski’s name. They will, however, help Stanislaw Burzynski in his battle against the FDA and the Texas Medical Board. Unwittingly, blinded by a noble desire not to cause the family any more pain than they are already enduring, people conflate “respecting the family’s decision” with not telling them they’re making a huge mistake, which, if they are successful, will result in their loved one undergoing a toxic therapy with no better chance of helping him than conventional treatment while, even worse, it will allow Stanislaw Burzynski to prey on cancer patients again. Desperate to help their loved ones, these families have become unwitting pawns in Burzynski’s battle with the authorities, while all the well-meaning, good people who do things like hold fundraisers in their pizza parlors to help these families have also become pawns.

Again, I realize that’s harsh, but that’s what Burzynski counts on: No matter how much his critics try to sugar coat their criticisms, they will be accused of “attacking patients.” Indeed, that’s a huge part of the entire message of the section on “The Skeptics” in Eric Merola’s second movie about Burzynski: To paint them as heartless bastardscackling over the misfortune of cancer patients seeking out Burzynski’s concoction and hoping that they die. Nothing could be further from the truth. My way of respecting the families of Burzynski patients is to assume that they will be able to handle coming across science-based analyses of Burzynski’s claims and actions in their Google searches and, yes, evenanalyses of the testimonials of patients who believe they’ve been cured by Burzynski to show that there’s no convincing evidence that Burzynski has been responsible for saving a single cancer patient. I realize that it’s probably too late for families like the ones described here. But if I prevent even a single new family from falling under Burzynski’s spell or even a single legislator from harassing the FDA on Burzynski’s behalf, I will consider my efforts to have been worth it. The real petitions and investigations that should be going on are asking our representatives and Kathleen Sebelius, Secretary of Health and Human Services, the Department in which the FDA is housed in the federal government, why the FDA has let Burzynski get away with his abuse of cancer patients and clinical trials for 37 years.

33 Comments

Frequently, victims of a con don’t want to admit that they’ve been conned. Burzynski’s patients, and the next-of-kin of his patients who have died, are in this category. I’ve even seen this happen in cases where the only loss was pride: a guy I knew in college once offered several people a liquid which he identified as a traditional Taiwanese beverage (it was actually soy sauce), and his earlier victims helped him to draw in his later victims. I can see how people who have spent thousands of dollars on Burzynski’s treatments might double down on that position.

It’s also quite revealing that Szabo’s routine request for comment was met with an eight-page legal threat. Burzynski and his lawyer must have assumed that Szabo would back off, as others had before. But Szabo is an all-too-rare creature: a real journalist in a position to commit acts of real journalism. The last thing you want to do when such a person calls is act like you have something to hide.

What I frequently try to point out to people bringing up Elisha Cohen’s case is that the FDA has not actually forbidden the use of neoplastons. The FDA has only forbidden the use of Burzynski. Surely if there were something to the whole neoplaston idea, you’d find another doctor willing to treat you with them.

And it isn’t like Burnzynski’s patents are either expired or just about to expire – at this point, if anyone else was interested, they should certainly be either doing so or getting prepared to do so….I agree, that fact that no one else in the world seems to want to touch these things should tell you something.

A clarification: Antineoplastons represent an unapproved drug. Consequently, they cannot be used in routine clinical practice. They can only be used in the context of an approved clinical trial. Aside from Hidaeka Tsuda in Japan, there are no other investigators besides Burzynski running clinical trials with antineoplastons of whom I’m aware. So shutting Burzynski down basically means no more antineoplastons, at least in the U.S., because, as you point out, no reputable researcher that I’m aware of is interested in carrying out clinical trial research using them. This has been true since the last time Burzynski collaborated with the Mayo Clinic and others to carry out clinical trials. The clinical trials were resoundingly negative, and Burzynski was such a pain to work with that no one else wanted to work with him.

Wonder if Randy Barnes would accept his own argument as a valid defense of parents choosing other unproven alt med treatments, for indications other than cancer, which are also known to cause serious side effects and for which there’s no evidence of efficacy?

Consider autism–does he support a parent’s right to choose chemical castration (a la the Geirs)?

How about bleach enemas?

“The autistic chilld’s parents are the only ones with the right and responsibility to make the best decisions they can in a horrible situation that no one who is not caring for an autistic child can possibly understand. The family is fully aware of the controversy and have read the articles on bleach enemas using industrial grade bleaches like Miracle Mineral Solution. However, they have also spoken to people who are convinced that bleach enemas recovered their autistic children.”

Or is this argument somehow only supposed to be apply when we’re talking about cancer and the use of ANP’s?

“which, if they are successful, will result in their loved one undergoing a toxic therapy with no better chance of helping him than conventional treatment while, even worse, it will allow Stanislaw Burzynski to prey on cancer patients again”

Is this just poor phrasing or am I misunderstanding? I read this as meaning ANP works as well as conventional treatment but no better? Whereas I was under the impression that there is no scientific evidence that ANPs work at all.

Please excuse my ignorance, but I, as a layperson, would never think to call someone an oncologist who didn’t even complete the requisite training? Am I at risk of consulting a doctor who says they are, say, an orthopedic surgeon who has actually never touched a scalpel, or does this tend to only happen in the Land of Woo?

You have me a bit alarmed as a patient -granted, I usually try to know a bit about the doctor I am seeing before “hiring” them, but though I have read repeatedly “Burzynski is not an oncologist,” it never occurred to me until today that there might be other MD’s out there playing the same word games.

@Chuff: There are still many cases of cancer which are beyond the reach of conventional medicine. The best that can be done in such cases is palliative care, to make the patient’s remaining time as painless as possible. This is one reason why Burzynski is able to operate as he currently does: many of these patients, and their families, aren’t willing to take “no” for an answer to the question of whether they can be saved. Denial ain’t just a river in Africa. So when someone like Burzynski answers that question with “Yes, but it will cost you …”, many people will jump at the chance, notwithstanding the alarm bells that should be going off.

Is this just poor phrasing or am I misunderstanding? I read this as meaning ANP works as well as conventional treatment but no better?

That’s what you read into it. All it means is that it’s possible that ANPs might have some minimal antitumor activity but that we know it’s not, as Burzynski says, as as good as conventional therapy (which is quite crappy for some of these tumors).

@Mrs Woo: It depends on jurisdiction, but in most US states, all you need is an MD (or equivalent degree, as specified by state law–unfortunately, in some states that means NDs and ODs) and a license to practice medicine in that state. Some states require a board certification of doctors claiming a specialty, but others do not. I don’t know specifically about Texas law, but based on what I know of that state, I would expect them to be less strict than some.

“That’s what you read into it. All it means is that it’s possible that ANPs might have some minimal antitumor activity but that we know it’s not, as Burzynski says, as as good as conventional therapy (which is quite crappy for some of these tumors).”

Ahhh. Thanks, that explains it.

@Eric, I fully agree. I feel that if he genuinely believed ANPs worked there would have been a flood of positive trials by now. Either that or there is some serious self-delusion going on.

There’s limited possibilities re: Burzynki believing ANP’s work, given that he’s been giving them to patients for more than 3 decades under the legal fiction of conducting Phase II clinical trials.

One, the data shows that they aren’t effective but he’s withholding publication in order to continue to run a lucrative practice providing desperate patients treatment he knows doesn’t work. In which case he’s the worst kind of conman.

Or the data show ANP’s do work, but he’s withholding publication in order to maintain a very lucrative monopoly on a cure for cancer, preventing it from being adopted as standard of care and denying the millions of cancer patients worldwide who can’t raise enough money to travel to texas and be enrolled at his clinic access to a cure for the cancer that will kill them.

I have decided to look on the “bright side” of this: Most people given the horrible news of a terminal cancer do NOT seek SB’s bogus treatment. We need to tell a few of their stories–how they coped, how the medical establishment treated them (medically and otherwise).

Forgive me if this has been covered elsewhere, but perhaps a regular wouldn’t mind explaining to a fellow minion what the supposed mechanism of ANP therapy even is? It seems like Burzynski treats (*ahem*) a lot of brain tumors, but can ANPs even cross the blood brain barrier?

@JGC: I think we can rule out your second option. If there were anything to ANPs as therapy, Burzynski would find it more profitable overall to run his trials by the book, and thereby avoid the scrutiny (and associated legal fees) he’s getting from the FDA and the Texas Medical Board. Or alternatively, his legal fees would be an investment in getting a lucrative contract to manufacture ANPs and distribute them to doctors performing those trials–his profit per patient would be less, but he’d make it up on volume.

Also, “conman” and “monster” are not mutually exclusive options.

@Dorothy: I like your idea. Certainly, many terminal cancer patients accept their prognosis. It’s likely that others look into the alleged treatments Burzynski and others offer and conclude that they can’t (or are unlikely to, or are not worth the price to) deliver on their promises.

IMHO, the ‘accidental’ release of records blamed on the FDA sounds like a defense/delay tactic by Stanislaw Burzynski. As long as everyone is talking about the release of records they aren’t talking about the actual treatments and the ethics of offering up expensive and profitable false hope to cancer patients. Odds are the fall guy within the Burzynski staff has already been selected and paid off. After some psychodrama to allow the organization to express how much they love their dedicated staff and how sad they are having to let them go the selected person will finally admit that hey did the deed and reflexively blamed the always bullying FDA. It will all be stage managed for effect and be assured that the sacrificial lamb will won’t suffer much and can expect to get a job within one of the larger anti-vaccine organizations after an appropriate interval so that few notice.

Burzynski first suggested that cancer is ‘a disease of cellular information processing and antineoplastons seem to ‘correct the program inside the cell’ changing a cancerous cell back to a normal cell. (Then again, he also claims that they aren’t toxic and that they aren’t chemotherapy.)

He’s since moved on to suggest tmultiple other possible mechanisms–that they work by inhibiting oncogenes, by suppressing protein synthesis, and by activating tumor suppressor genes.

The latter proposed mechanisms are presumably based on the fact that antineoplastons are metabolites of a known drug, sodium phenylbutyrate, a histone deacetylase inhibitor which has been seen to inhibit protein synthesis in cultured cells. In prostate cancer cell lines–and again in culture–PB has been seen to inhibit VEGF production and to induce apoptosis.

This would seem to me to be a more plausible mechanism by which ANP’s might act, if cancer cells were more sensitive to ANP’s than normal cells and if a therapeutic circulating level could be achieved with an acceptable side effect profile. That doesn’t appear to be the case, however: a number of clinical trials looking at sodium phenylbutyrate as a cancer treatment have been conducted by researchers other than Burzynski (including at least one in glioma patients, Stan’s berad and butter) but show no evidence it holds promise as a treatment for advanced cancers.

Central to the staff member’s outrage is the fact that the parents gained access to their child’s records. Presumably those records were Burzynski IP.

For the parents, this was evidently the first revelation that their child died from clinical malpractice. What had Burzynski told them previously?

Szabo:

“I read about N’s case in a document that Dr. Burzynski sent to the FDA, in response to its ongoing investigation.”

ANH-USA:

This seemed to confirm the allegation that the FDA had given the reporter confidential patient information. […] The first statement appears to have been an attempt to protect the identity of the person who did provide the confidential patient information.

This bizarre wordtwisty misreading — to explain why they accepted the Burzynski defamation of Szabo & the FDA without bothering to check with either — suggests that they are uncomprehending idiots, or Burzynski sockpuppets. Or of course they could be both.

There is a third option, which is of course the ‘true believer’ option. He’s convinced that ANPs work. ANPs don’t work in other places because interfering and skeptical doctors prevent patients from actually following the protocols. (See the previously-mentioned third-party test that was called off due to the side effects.) If you look at all the evidence through properly rose-coloured glasses, every single failure gets written off as somebody else’s mistake, because of course the ANPs work, why would he have spent all his life pushing this if they don’t work?

There is no bright side to the Burzynski Clinic. That some people don’t end up there is cold comfort. All we can do is make sure it does NOT happen again. And you can help. And you should if you’re mad about what’s been going on. You have a chance of ending something as ethical, in my opinion, as the Tuskegee Experiment, which has gone on just as long, included 8X as many people, and went on while the FDA was giving him horrible site review after horrible site review and letting it continue. NOW STOP KVETCHING–STEP UP AND HELP US STOP IT! thehoustoncancerquack.com

I’m a longtime reader but only chiming in now because this is getting into one of my areas of expertise: administrative law. I have a lot of hope that this case will stick, if only because the current FDA agency head and staff have shown that they are focused on science over politics. This is the agency that approved the Plan B availability for teenagers without a prescription (a decision which was overturned by the head of the HHS, but the HHS wouldn’t have any power over the due process hearing that would be involved in this case). If anything, I don’t think it would be political pressure stopping them but concerns about the best use of funds. There is no question that this guy is going to appeal a negative decision, and the agency might wonder if the time and money spent on 5 years of appeals might be better spent on other things. That should be what anyone says when contacting a representative about the issue; that this is the type of issue that we want tax money being spent on because it is costing lives and giving people false hope.

Don’t forget that (as reported on this blog), antineoplaston therapy has also been proposed as a preventative against aging (Stan authored a paper on this some years ago, and an antineoplaston-containing supplement has been touted for use against aging and Alzheimer’s):

antineoplaston therapy has also been proposed as a preventative against aging (Stan authored a paper on this some years ago

At the same time, he is careful to market his anti-aging products under the Aminocare label, to keep them separate from his main operation, so he is presumably aware that it is not a good look to have too many fingers in the alt-health care. But at the same time, the thought of a pool of money out there for anti-aging products — and none of it going to him — is too strong to resist.

The Aminocare side-line is the strongest evidence against the “sincerely deluded” interpretation of Burzynski’s behaviour.

[…] You Can Help, promoting the Burzynski line. Once again, as I’ve described it, Burzynski is using patients as a weapon and a shield against the FDA. Unfortunately for him, he can’t see to keep himself and his minions from letting the […]

[…] Cohen, a six-year-old child with medullablastoma who is not doing well and whose parents have been at the forefront of pressuring the FDA. As horrible as the Cohens’ situation is—and we all understand that it’s a horrible, […]